STAT+: ‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval

“It creates a concerning precedent that could be applied to other accelerated approval drugs in the future,” said John Maraganore, former CEO of Alnylam Pharmaceuticals.

Whither accelerated approval?

Amid the hubbub over new Medicare coverage restrictions for Alzheimer’s treatments, a key issue may not be fully appreciated: There is now bona fide pushback against accelerated approval, a controversial strategy used by regulators and companies to get new drugs to market faster than usual.

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